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ISRCTN
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ISRCTN78846684
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ClinicalTrials.gov identifier
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Public title
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The prevention of lower extremity physical activity injuries: a school-based randomised controlled trial in children aged 10 - 12 years
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Scientific title
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Acronym
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iPlay
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Serial number at source
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NTR580
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Study hypothesis
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The promotion of safe sports participation proves effective in a physical education setting, resulting in a reduction of lower extremity injuries in children.
Please note that as of 19/12/2008 the anticipated start and end dates in this record were amended. The previous dates are as follows:
Initial anticipated start date: 01/10/2005
Initial anticipated end date: 01/10/2008
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Lay summary
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Not provided at time of registration
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Ethics approval
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The Medical Ethics Committee of Vrije University Medical Centre approved the study design, protocols and informed consent procedures on 6th July 2006
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Study design
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Randomised active controlled parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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No condition, healthy person
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Participants - inclusion criteria
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Primary schools: boys and girls aged 10 - 12 years.
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Participants - exclusion criteria
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Does not comply with the above inclusion criteria
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Anticipated start date
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01/09/2006
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Anticipated end date
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30/07/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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2280
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Interventions
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The study will be carried out during one school year in primary schools, reaching boys and girls aged 10 - 12 years (7th and 8th grade). Schools will serve as randomisation units to avoid spill-over of the intervention within schools and to enhance control over intervention adherence and compliance.
The injury prevention programme aimed at lower extremity injuries in children aged 10 - 12 years was constructed based on an intervention mapping protocol. In general the injury prevention programme focuses on injury prevention in general and focuses on injury awareness, physical fitness and coordination (motor control). In addition the programme focuses on soccer, tennis, basketball, inline skating and snowboarding. These are the most commonly practiced activities in this age group. The injury prevention programme will be given by the children's teachers as a 9 month course.
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Primary outcome measure(s)
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1. Incidence of lower extremity injuries
2. Costs associated with lower extremity injuries
Primary and secondary outcomes measured September/October 2006 and June/July 2007.
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Secondary outcome measure(s)
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Change in attitudes and behaviour with regards to injury and injury prevention. Primary and secondary outcomes measured September/October 2006 and June/July 2007.
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Sources of funding
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Trial website
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Publications
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1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21092316
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Contact name
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Dr
D.M.
Collard
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Address
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VU University Medical Center
EMGO-Institute
Van der Boechorststraat 7
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City/town
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Amsterdam
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Zip/Postcode
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1081 BT
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Country
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Netherlands
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Email
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dorine.collard@vumc.nl
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Sponsor
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Vrije University Medical Centre (VUMC) (The Netherlands)
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Address
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EMGO Institute
Van der Boechorststraat 7
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City/town
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Amsterdam
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Zip/Postcode
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1081 BT
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Country
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Netherlands
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Tel
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+31 (0)20 444 8180
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Fax
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+31 (0)20 444 8181
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Email
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emgo@vumc.nl
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Sponsor website:
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http://www.vumc.nl/
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Date applied
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08/03/2006
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Last edited
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15/08/2011
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Date ISRCTN assigned
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08/03/2006
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